Table 1 Patient inclusion and exclusion criteria

Criteria

Patients satisfying all of the following requirements are eligible.

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Outpatients aged 20 years or over at the time of consent acquisition

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Patients with schizophrenia satisfying the DSM-IV-TR diagnostic criteria

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Patients requiring antipsychotic treatment or switching from the current antipsychotic medication to others because of lack of efficacy, intolerability, or other reasons

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Patients capable of issuing consent to participate in the study in writing

Exclusion criteria

Patients falling under any of the following criteria are excluded from this study.

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Patients having a history of allergy to any component of the test drugs or risperidone

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Patients under strong influence from drugs that suppress the central nervous system, such as barbiturate derivatives

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Patients receiving adrenaline

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Patients receiving azole antifungal agents (excluding topical preparations) or HIV protease inhibitors

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Patients with moderately or severely compromised renal function (creatinine clearance less than 50 mL/min at the time of eligibility assessment)

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Patients with poorly controlled diabetes mellitus (HbA1c (NGSP) over 8.4% at the time of eligibility assessment)

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Patients presenting with severe symptoms despite sufficient antipsychotic treatment or patients having a history of clozapine therapy

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Patients having other psychiatric disease in addition to schizophrenia

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Patients with complication of Parkinson’s disease

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Patients presenting with malignant syndrome or similar symptoms or patients with water poisoning

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Patients having signs of physical exhaustion, such as dehydration and malnutrition

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Patients having malignant tumor requiring treatment

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Patients with a history of alcohol or drug abuse

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Pregnant or possibly pregnant women, lactating women, or women desiring to become pregnant during the study period

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Patients likely to attempt suicide (CGI-SS class 4 or higher (severe tendency for suicide))

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Other patients judged by the physician in charge as inappropriate for the study